EUCTR2008-004148-35-IE进行中（未招募）不适用
Cilengitide and cetuximab in combination with platinum-based chemotherapy as first-line treatment for subjects with advanced NSCLC.Open-label, randomized, controlled, multicenter Phase II study investigating 2 cilengitide regimens in combination with cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone as first-line treatment for patients with advanced NSCLC (CERTO). - CERTO
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 215
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent obtained before undergoing any study-related activities.
- •2. Male or female, at least18 years of age.
- •3. Histologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV.
- •4. Archived tumor material sample for retrospective central histology, KRAS mutational analysis, EGFR status, and further biomarker research.
- •5. At least 1 radiographically documented measurable lesion in a previously non-irradiated area according to RECIST, i.e. this lesion must be adequately measurable in at least one dimension (longest diameter [LD] to be recorded) as =2 cm by conventional techniques or =1 cm by spiral CT scan.
- •6. ECOG performance status 0-1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment with an antibody or molecule targeting endothelial growth factor receptor (EGFR)- and/or vascular endothelial growth factor receptor (VEGFR)-related signaling pathways.
- •2. Previous chemotherapy for NSCLC.
- •3. Brain metastasis and/or leptomeningeal disease (known or suspected).
- •4. Radiotherapy (except localized radiotherapy for pain relief), major surgery or intake of any investigational drug in the 30 days before the start of study treatment entry.
- •5. Concurrent chronic immunosuppressive or hormone anti-cancer therapy (physiologic hormone replacement is allowed).
- •6. History of coagulation disorder associated with bleeding or recurrent thrombotic events.
- •7. Recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of study treatment start.
研究者
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